BAY94-8862, Interaction Study with Ompeprazole and Maalox
Primary objective: To investigate
- The influence of a co-administration of a single dose of 10 mL Maalox 70 mVal suspension and
- A 4-day pre- and co-treatment of 40 mg omeprazole once daily (given as 2 x 20 mg Antra)
on the pharmacokinetics of BAY 94-8862 given as a 10 mg immediate release tablet single dose in comparison to a single oral dose of 10 mg BAY 94-8862 alone in a 3-fold crossover, randomized, open-label design in healthy male subjects.
Secondary objectives: To assess safety and tolerability of BAY 94-8862.
- Healthy male white subjects; 18 to 46 years of age; body mass index ≥18 and ≤29.9 kg/m*2.
- Recent donation of blood/blood components - Subjects hypersensitive to investigational drugs, their components and/or with a history of multiple drug allergies, non-allergic drug reactions, or severe allergies - Galactose and fructose intolerance - Lactase, saccharase-isomaltase or vitamin B12 deficiency, hypo- or hyperchlorhydria, hypophosphatemia, porphyria - Medical conditions/disorder/illness that would impair subject’s ability to participate in the trial or that may affect study results - Positive testing in drug screening - Subject is tested to be human immunodeficiency virus 1/2 antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies positive - Clinically relevant changes/deviations from normal range in electrocardiogram, clinical examination, clinical chemistry, hematology, urinalysis, serum potassium ≥5.0 mmol/L, serum sodium ≤130 mmol/L, and/or vital signs (blood pressure, heart rate) - Regular daily consumption of a certain amount of beer, alcohol, cigarettes, xanthine or grapefruit-containing beverages that may affect study results - Regular use of therapeutic or recreational drugs - Use of medication within the 2 weeks preceding the study which could have interfered with the investigational product; especially concomitant use of: Potassium-sparing diuretics, ACE inhibitors, angiotensin-II-receptor blockers, potassium or calcium supplements, non-steroidal anti-inflammatory drugs, strong CYP3A4 inducers, Weak to moderate CYP3A4 inhibitors, strong inhibitors of CYP3A4 or strong inhibitors of CYP2C8, macrolide antibiotics, digoxin, warfarin, terfenadine, astemizole, cyclosporine, cisapride, tacrolimus or atazanavir, prokinetic or anticholinergic drugs
Köln, Germany, 51063
E-mail: [email protected]
Phone: (+)1-888-84 22937
Interaction study to investigate the influence of a co-administration of a single dose of 10 mL Maalox® and a 4-day pre- and co-treatment with omeprazole 40 mg OD, respectively, on the pharmacokinetics of a single dose of 10 mg BAY 94-8862 IR-tablet in a threefold crossover, randomized, open-label design in healthy male subjects